Status:
COMPLETED
Redox Imbalance and the Development of Cystic Fibrosis Diabetes
Lead Sponsor:
Emory University
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Diabetes Mellitus, Type 2
Cystic Fibrosis
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
Cystic fibrosis-related diabetes (CFRD) occurs in almost 20% of teens and 50% of adults. The investigators' long term goal is to determine the cause of CFRD in order to translate this knowledge into t...
Detailed Description
Aim 1: Three groups of subjects will be evaluated: 1. 27 CF children with class I-III mutations aged 1 to 9 years with normal glucose tolerance (NGT), 2. 27 age-matched controls with NGT, and 3. 15 CF...
Eligibility Criteria
Inclusion
- Aim 1
- For CF children with class I-III mutations
- CF diagnosed by pilocarpine electrophoresis sweat test and/or CFTR genetic mutation analysis
- CFTR mutation analysis showing two Class I to III mutations
- Aged 1-9 years
- On a clinically stable medical regimen for at least three weeks
- No IV or oral antibiotics for a respiratory exacerbation for at least three weeks
- No hospitalization for at least six weeks
- For CF children with class IV-VI mutations
- CF diagnosed by pilocarpine electrophoresis sweat test and/or CFTR genetic mutation analysis
- CFTR mutation analysis showing at least one Class IV-VI mutation
- Aged 1-9 years
- On a clinically stable medical regimen for at least three weeks
- No IV or oral antibiotics for a respiratory exacerbation for at least three weeks
- No hospitalization for at least six weeks
- Not taking pancreatic enzyme replacement therapy
- For age-matched controls
- No acute illness for at least six weeks
- Never been hospitalized except at birth following a full term delivery
- Aged 1 to 9 years
- Without any chronic illness requiring prescription medications
Exclusion
- Current or past diagnosis of CFRD (for CF children)
- Parents unwilling to have an IV inserted for blood draws
- Aim 2a
- Inclusion Criteria:
- CF diagnosed by pilocarpine electrophoresis sweat test and/or CFTR genetic mutation analysis
- CFTR mutation analysis showing two Class I to III mutations
- Aged 12 years or older
- On a clinically stable medical regimen for at least three weeks
- No IV or oral antibiotics for a respiratory exacerbation for at least three weeks
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02202876
Start Date
November 1 2014
End Date
September 9 2018
Last Update
June 4 2020
Active Locations (1)
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1
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, United States, 30322